Methods of using an enhanced therapeutic stimulus for non-nutritive suck entrainment system

ABSTRACT

The present invention relates to methods of using a therapeutic system. In particular, the present invention relates to procedures and methods of using a system having hardware, software, and appliance components for assessing and entraining a non-nutritive suck (NNS) pattern in a patient. The methods include configuring the hardware and software systems to receive data from an orofacial stimulation appliance and to generate a precise therapeutic pulse profile that is actuated as a tactile stimulus. The methods also include collecting data using the orofacial stimulation appliance and delivering the tactile stimulus via the orofacial stimulation appliance to entrain an organized NNS pattern.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/457,154, filed Apr. 26, 2012, which is a continuation-in-part of U.S.patent application Ser. No. 12/390,142, filed on Feb. 20, 2009, whichclaims priority to U.S. Provisional Application No. 61/036,304, filed onMar. 13, 2008, and U.S. Provisional Application No. 61/030,484, filed onFeb. 21, 2008, all of which are incorporated by reference in theirentireties.

FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

The subject matter discussed in this patent application was funded inpart by United States Grant No. R01-DC003311 from the National Instituteof Health (NIH). The government may have certain rights to the subjectmatter discussed herein.

FIELD OF THE INVENTION

The invention relates generally to methods and procedures using hardwareand software systems, including any processing devices or appliancesincorporating the software system to assess the organization of anon-nutritive suck (NNS) pattern of a patient and to entrain anorganized NNS pattern in the patient. More specifically, the presentinvention relates to methods of monitoring and administering tactilestimuli to assess the patient's natural NNS pattern and to entrain anorganized NNS pattern.

BACKGROUND OF THE INVENTION

Premature birth places infants at increased risk for learningdisabilities, delayed development of speech, language and motor skills,and mortality. The premature infant often has difficulties withrespiration and feeding and therefore may remain in the hospital forprolonged periods of time. The non-nutritive suck (NNS) is a motorbehavior that can be observed and used to make inference about braindevelopment and organization in this young population.

Oral stimulation therapy is a common practice, in which feedingtherapists manually apply a stimulation using their fingertip. Manuallyapplying stimulation, however, has a number of drawbacks. One suchdrawback includes the variance and limitation in the amount of motion(amplitude) and rhythm (frequency) from therapist to therapist, or evenby the same individual. As a result, extensive and costly training andexperience are required for a therapist to be proficient at providingmanual stimulation and assessment.

In addition, manual stimulation is given essentially blind, as patientscan respond by producing a variety of undesirable motor actions,including but not limited to clenching the jaws, tongue compression,tongue thrusting, or other reactions that may be confused with desirableNNS events. As such, it can be difficult to determine if the manualstimulation is beneficial to the patient.

Therefore, a need exists for an automated system and method of using thesystem to assess a patient's natural NNS pattern and to provide preciseand beneficial tactile stimulus to correct and organize the patients NNSpattern.

SUMMARY OF THE INVENTION

The present invention relates to a method of using a system havinghardware, software, and appliance components for assessing andentraining a non-nutritive suck (NNS) pattern in a patient. In oneaspect, a method is performed using a non-nutritive suck applianceassembly in communication with a non-nutritive suck application systemto assess a non-nutritive suck pattern of patient. The method includessteps performed at a user interface generated for display on a displaydevice of the non-nutritive suck application system. The steps includeselecting the patient's name from a displayed list of patients generatedby the non-nutritive suck application system, the non-nutritive suckapplication system having memory and executing a non-nutritive suckapplication on at least one processor. The steps also include selectingan assessment mode of the non-nutritive suck application, selecting adisplayed “new assessment” control button, selecting an assessment to beperformed at the user interface and configuring the assessment at theuser interface.

The method also includes steps for calibrating an orofacial stimulatorappliance of the non-nutritive suck appliance assembly to perform theselected assessment procedure. The method further includes the steps ofpositioning the patient to encourage a rooting response to the orofacialstimulator appliance, starting the assessment, and inserting theorofacial stimulator appliance into the patient's mouth. The orofacialstimulator appliance is held to maintain contact with the patient'smouth during the assessment, and then removed from the patient's mouthat the conclusion of the assessment session. The method also includesproviding summary remarks regarding the assessment at the userinterface.

In another aspect, a method is performed using a non-nutritive suckappliance assembly in communication with a non-nutritive suckapplication system to entrain a non-nutritive suck pattern of a patient.The method includes steps performed at a user interface generated fordisplay on a display device of the non-nutritive suck applicationsystem. The steps include selecting the patient's name from a displayedlist of patients generated by the non-nutritive suck application system,the non-nutritive suck application system having memory and executing anon-nutritive suck application on at least one processor. The steps alsoinclude selecting a therapy mode of the non-nutritive suck application,selecting a displayed “new therapy” control button, and, configuring atherapy protocol to be performed.

The method also includes steps for calibrating an orofacial stimulatorappliance of the non-nutritive suck appliance assembly to perform theselected therapy protocol. The method further includes the steps ofpositioning the patient to encourage a rooting response to the orofacialstimulator appliance, starting the selected therapy protocol, andinserting the orofacial stimulator appliance into the patient's mouth.The orofacial stimulator appliance is held to maintain contact with thepatient's mouth during the therapy protocol, and then removed from thepatient's mouth at the conclusion of the therapy protocol. The methodalso includes providing summary remarks regarding the therapy protocolat the user interface.

In yet another aspect, a method is performed using a non-nutritive suckappliance assembly in communication with a non-nutritive suckapplication system to generate a productive non-nutritive suck patternin a patient. The method includes assessing a current non-nutritive suckpattern of the patient, as described herein, reviewing an assessmentwaveform received by the non-nutritive suck application from theorofacial stimulator appliance, determining if a therapy protocol isnecessary to generate the productive non-nutritive suck pattern, andproviding a therapeutic stimulus to the patient, as described herein.

In other aspects, the method further includes administering a therapyprotocol by using the hardware, software, and appliance components togenerate a therapeutic pressure pulse signal comprising a base frequencysignal further comprising two or more pressure pulses, wherein eachpulse period consists of a positive and negative displacement contactedby the lip and the mouth of the patient. Pulses are administered in aseries of two or more pulses, and each of the two or more pressurepulses has a damped harmonic oscillating square wave profile and areseparated by an interval between 500 milliseconds and 650 millisecondsin duration. The method may also include generating a therapeuticpressure profile signal comprising at least one of the therapeuticpressure pulse signals and transmits the therapeutic pressure pulseprofile signal to the orofacial stimulator appliance.

In various aspects, the base frequency is between 1.5 Hz and 5 Hz andthe two or more pressure pulses causes surface motion of between about260 microns and 300 microns, with a maximum transition interval of 20milliseconds to 50 milliseconds. The therapeutic pressure profile mayinclude at least six pressure pulses in succession contacted with thepatient for at least two minutes, at least twice a day. Further, each ofthe two or more pressure pulse is composed of higher order harmonics ofthe base frequency and each pressure pulse has a square wave peak.

In various aspects, the methods further comprise calibrating theorofacial stimulator appliance by mounting a pacifier onto an end of theorofacial stimulator appliance or optionally, inserting a therapy insertinto a receiver tube of the orofacial stimulator appliance. In addition,the calibration of the orofacial stimulator appliance, as well as theexpansion characteristics of the pacifier may be verified prior to,during, or after use. Verification may be performed by measuring thefrequency and amplitude of changes in the pacifier by a lasermicrometer. In particular, the frequency and amplitude of the changes inthe pacifier shape may be reviewed to verify that the desired therapypulse is applied.

In addition, various aspects of the methods include providing summaryremarks that may include data regarding a state of alertness for thepatient.

The methods may also include steps for providing power to thenon-nutritive suck application system, providing power to thenon-nutritive suck appliance assembly, verifying a charge of a batteryback-up unit, and logging in to the non-nutritive suck application.Further, the methods may have steps for adding a new patient to thedisplayed list of patients. Adding a new patient includes the steps ofselecting an “add new patient” control button at the user interface,entering new patient data at the user interface, and, selecting a “save”control button to save the new patient data in the memory of thenon-nutritive suck application.

In addition, at least one of the assessment session or the therapyprotocol may be started by selecting a “start assessment” control buttonor a “start therapy” control button, respectively, at the userinterface. Alternately, at least one of the assessment or the therapyprotocol may be started by depressing a button on the orofacialstimulator appliance. Related objects and advantages of the presentinvention will be apparent from the following description.

DESCRIPTION OF FIGURES

FIG. 1 is a block diagram of a non-nutritive suck assessment andentrainment system according to one aspect.

FIG. 2 is a block diagram of computing environment according to oneaspect of the non-nutritive suck assessment and entrainment system.

FIG. 3 is a block diagram of data source according to one aspect of thenon-nutritive suck assessment and entrainment system.

FIG. 4 is a block diagram of a non-nutritive suck entrainmentapplication according to one aspect of the non-nutritive suck assessmentand entrainment system.

FIG. 5 is a block diagram of a system module according to one aspect ofthe non-nutritive suck assessment and entrainment system.

FIG. 6 is a block diagram of an assessment module according to oneaspect of the non-nutritive suck assessment and entrainment system.

FIG. 7 is a block diagram of a therapy module according to one aspect ofthe non-nutritive suck assessment and entrainment system.

FIG. 8A is a block diagram of a therapeutic pulse generation systemaccording to one aspect of the non-nutritive suck assessment andentrainment system.

FIG. 8B is a block diagram of an orofacial stimulator applianceaccording to one aspect of the non-nutritive suck assessment andentrainment system.

FIG. 9 is a block diagram of a non-nutritive suck assessment andentrainment system according to one aspect.

FIG. 10 illustrates a method for assessing a non-nutritive suck patternaccording to one aspect of the non-nutritive suck assessment andentrainment system.

FIG. 11 illustrates a method for stimulating a patient to entrain anorganized non-nutritive suck pattern according to one aspect of thenon-nutritive suck assessment and entrainment system.

FIGS. 12-31 are screenshots of various graphic user interface displaysaccording to aspects of the non-nutritive suck assessment andentrainment system.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a system for assessing and the neuralentrainment of a Non-Nutritive Suck (NNS) pattern in a patient.Typically, the patient is a premature infant; however, the system mayalso be used for patients unable to properly suck or swallow to receivenourishment, including but not limited to full-term infants, toddlers,adolescents, and adults. For example, the system may be used to treatthose that have been debilitated by strokes, hemorrhages, or otherconditions that correlate with an impairment in neurological developmentor function.

The NNS pattern of a patient is generated by the patient's suck centralpattern generator (sCPG). A central pattern generator (CPGs) is a neuralcircuit or combination of neural circuits located in the patient'scerebral cortex, brainstem, and/or spinal cord that drives rhythmicmotor behaviors such as sucking, breathing, mastication, and locomotion.The patterns generated by the CPGs can be modulated by a variety ofexternal stimuli. As such, the most beneficial therapeutic results aremanifested when the therapy consistently mimics the intrinsic frequencyof sCPG.

It is often difficult for therapists to model the fine temporalstructure of an organized NNS burst pattern, which involves afrequency-modulated (FM) burst structure, using manual stimulation. TheFM burst structure is characterized by a series of suck cycles thatsuccessively decrease in frequency from the first compression cycle ofthe lips and mouth to the last compression cycle. The FM burst structuretypically modulates between 1.5 Hz and 3 Hz. The structure of the FMburst is very difficult if not impossible to produce manually in arepeated pattern by even the most experienced therapist.

The present invention relates to the identification of particularcharacteristics of the FM burst structure and provides criteria ordescriptions of features of the NNS pattern that may be used asdiagnostic indicators for gauging the development of oromotor controlamong patients. Further, the identified characteristics may be useful inconfiguring a tactile stimulus that may be applied to patients to modifyor correct a deficient NNS pattern.

The Non-nutritive Suck (NNS) Application System (NNS Application system)

FIG. 1 is a block diagram of a non-nutritive suck (NNS) assessment andentrainment application system (NNS application system) 100 forassessing a patient's natural NNS pattern and for providing a tactilestimulus that will stimulate the suck central pulse generator (sCPG) andtrigeminal nerve of a human brain to entrain a proper NNS pattern.Further, the NNS application system 100 may be used to assess andentrain brain activity for controlling respiration, mastication, orcombinations thereof. The NNS application system 100 includes acomputing device 102 to process data and execute one or moreapplications, a data source 104 to store data, a pulse generation system106 to generate pneumatic pulses in response to input signals, and anorofacial stimulator appliance 108 to transfer the pneumatic pulses to apatient as a tactile stimulus.

According to one aspect, the computing device 102 includes memory 200and at least one processor 202 to execute a NNS assessment and therapyapplication (NNS application) 204, as shown in FIG. 2. The computingdevice 102 also includes a display 206, such as a computer monitor, fordisplaying data stored in the data source 104, data received from thepulse generation system 106 or the orofacial stimulator appliance 108,and data input by a user of the NNS application system 100. The displaydevice 206 also displays one or more graphical user interfaces (GUIs)input forms or displays, generated by the NNS application 204, as shownin FIGS. 12-31. The GUI input forms and displays enable a user of theNNS application system 100 to input, view, and/or interact with thevarious modules of the system. The GUI input forms and displays alsoallow a user to input, view, and/or interact with patient data, NNSassessment data, NNS therapy data, and/or other data related to theassessment and therapeutic stimulation of the patient. Further, the GUIinput forms and displays permit a user to configure and interact withthe pulse generation system 106 and the orofacial stimulator appliance108.

The computing device 102 may also include an input device 208, such as akeyboard or a pointing device (e.g., a mouse, trackball, pen, or touchscreen) to enter data or configure a feature of the NNS applicationsystem 100 using the GUI input forms and displays. The computing device102 may further include, or at least be in communication with, the datasource 104.

The data source 104 may be a database stored on a local hard disk drive(HDD) incorporated into the computing device 102. Alternately, the datasource 104 may be a database or other data structure stored remotelyfrom the computing device 102. For example, the computing device 102 maybe in communication with the data source 104 over a network, includingbut not limited to the Internet. As shown in FIG. 7, the data source maystore a variety of data. For example, the data source 104 may store userdata 700 that includes profiles and login information, such aspasswords, for users of the NNS application system 100. The data source104 may also contain patient data 702 including patient charts andhistorical assessment and therapy session data 704 and 706,respectively. The data source 104 also stores data for therapy protocolsor therapy pulse profiles 708 that may be used to entrain a variety ofpatients, as well as, other data 710 gathered from experiments orresearch trials conducted using the NNS application system 100.

According to one aspect, as shown in FIG. 3, the NNS assessment andtherapy application 204 includes a number of instructions, applets,modules 300-308, and submodules to receive, process, and generate dataand/or signals for the assessment of a NNS pattern and the therapeuticstimulation of a patient's mouth and lips to entrain a proper NNSpattern. The modules of the NNS assessment and therapy application 204include an NNS application system module 300, an assessment module 302,a therapy module 304, a leak detection module 306, and a research module308.

The NNS application system module 300 includes various submodules400-406 to provide access to various the features and functionality ofthe NNS assessment and therapy application 204. For example, the NNSapplication system module 300 includes a user login submodule 400 thatallows a user of the NNS application system 100 to login into the NNSapplication 204. In one aspect, the NNS application system module 300generates GUI input forms 1200 and 1202, as shown in FIGS. 12-13, wherethe user may select a user account and log in to the NNS application 204after entering a valid password for the selected user.

The NNS application system module 300 includes a user configurationsubmodule 402 that allows users of the NNS application system 100 withsufficient privileges to add, edit, or delete user accounts. By way ofexample and not limitation, an administrator may input data into GUIinput forms 1204 and 1206, as shown in FIGS. 14-15 to create, modify, ordelete a user profile to grant or restrict access to the NNS application204.

Similarly, the NNS application system module 300 includes a patientconfiguration submodule 404 that allows users of the NNS applicationsystem 100 with sufficient privileges to add, edit, or delete patients.By way of example and not limitation, an administrator may input datainto input forms 1208 and 1210, as shown in FIGS. 16-17, to create,modify, or delete a profile for a patient that may receive an NNSassessment or therapy using the NNS application system 100. The NNSapplication system module 300 also includes a session selectionsubmodule 406 that allows users of the NNS application system 100 toselect whether the NNS application system will be used to assess apatient's naturally generated NNS pattern or to provide therapeuticstimulus to the patient. As such, the session selection submodule 406sends requests to the assessment module 302 and the therapy module 404in response to type of session selected by the user.

When an assessment request is generated, the NNS application systemmodule 300 generates a main assessment input form 1212 to allow the userto input data and interact with the NNS application 204 during theassessment session. By way of example, and not limitation, an embodimentof the main assessment input form 1212 is shown in FIG. 18. In oneaspect, the main assessment input form 1212 includes one or more controlbuttons 1214 to access a list of all the patients actively associatedwith the NNS application 204. When a patient is selected, the mainassessment input form 1212 displays a history 1216 of assessments forthe selected patient, and is capable of displaying waveforms from theprevious assessments in a waveform frame 1218. In one aspect, the priorwaveforms and assessment histories 1216 may be stored as assessmentsession data 704 in the data source 104.

The main assessment input form 1212 also includes a control button 1220to permit a user to view a patient's medical chart 1294, an example ofwhich is shown in FIG. 31. In addition, the control button 1220 allowsthe user to add or edit patient data, while control button 1222 allowsthe user to add notes to the patient assessment data. In addition, theuser may select control button 1224 to start a new assessment sessionfor the selected patient or select control button 1226 to switchdirectly to a therapy session for the selected patient.

In one aspect, the assessment module 302 includes a number of submodules500-508, including but not limited to an assessment configurationsubmodule 500, an assessment calibration submodule 502, an assessmentcapture module 504, a feature extraction submodule 506, and a postassessment review module 508. The various submodules 500-508 generateand display one or more GUI input forms as shown in FIGS. 19-26 thatallow the user to configure, initiate, and review an assessment session.

The assessment configuration submodule 500, for example, generates anassessment configuration GUI input form 1228. The assessmentconfiguration GUI input form 1228 includes one or more controls1230-1242 and data fields 1244-1248 to input data for selecting orconfiguring an assessment session. The input data may relate to a totalassessment time 1246, an intermediate assessment prompt 1244, a type andconfiguration 1236 of the pacifier 810, and optionally, the patient'sweight 1248. As the behavior and mood of a patient is oftenunpredictable, it is difficult for the user to know in advance how longthe assessment session may take. Therefore, the intermediate assessmentprompt is selected as a ‘best estimate’ for the actual time that it maytake to capture enough NNS pattern activity to assess the patient. Assuch, the total assessment time permits the user to continue to collectdata, if desired, after the intermediate assessment prompt. In oneaspect, the assessment collection submodule 504 halts the capture ofassessment data at the intermediate assessment prompt.

The assessment calibration submodule 502 generates an assessmentcalibration GUI input form 1250. In one aspect, the calibration inputform 1250 allows the user to communicate with and configure the pulsegeneration system 106 and the orofacial stimulator appliance 108 toverify the intended function and calibration for the components of thepulse generation system and the orofacial stimulator appliance prior tothe initiation of an assessment session.

The assessment capture submodule 504 receives the digital pressuresignal from the pulse generation system 106. In one aspect, theassessment capture submodule 504 records and displays the patient's NNSpattern activity as a waveform 1252. In other aspects, the assessmentcapture submodule 504 may receive and store the digital pressure signalwithout displaying the NNS pattern activity. In another aspect, theassessment capture submodule 504 may display the NNS pattern activity inanother form, such as a chart, graph, or table.

The assessment capture submodule 504 may further generate a number ofdisplays during the assessment capture session. For example, FIGS. 22-25are screen displays that show the progress of the assessment session atthe start of the session 1254, at the intermediate prompt interval 1256,at the user input duration time 1258, and at the conclusion of theassessment session 1260. In other aspects, fewer or a greater number ofdisplays 1254-1260 may be provided during the assessment session.

In one aspect, the assessment data capture session may be initiated byinput received through a start control button 1262 shown on the display206. Alternately, the assessment data capture session may be initiatedby a switch 816 on a handpiece 806 of the orofacial stimulator appliance108.

During or subsequent to an assessment session, the feature extractionsubmodule 506 analyzes the digital pressure signal received by theassessment capture submodule 504. In particular, the feature extractionsubmodule 506 identifies various components of the patient's generatedNNS pattern. For example, in the waveform 1252 of FIG. 21, the featureextraction submodule 506 identifies pressure peaks 1264, individual suckevents 1266, as well as bursts 1268, which are defined as two or moresuck events in less than about 1.2 seconds. In addition, the featureextraction submodule 506 also identifies a number of non-NNS events1270, such as chewing motions made by the patient. In one aspect, thefeature extraction submodule 506 may provide annotations, includingcolor-coding, to identify the various NNS events 1264-1268.

In one aspect, the feature extraction submodule 506 quantifies theoverall performance of the patient's generated NNS pattern by assigninga Spatiotemporal Index (STI) value to the pattern. For example, the STIvalue may be derived by calculating the similarity of up to fiveindividual suck bursts. The STI value measures the symmetrical andrepetition of the patient's generated NNS burst pattern by integratingthe symmetry and quantity of selected NNS events 1264-1268 in thepatient's NNS pattern.

In another aspect, the feature extraction submodule 506 automaticallydetermines a number of parameters that are desirable for evaluating thepatient's generated NNS pattern and determining the best course oftherapy to treat the patient. For example, the evaluation parameters mayinclude the STI value for the waveform, the number of bursts per minute,the number of events per burst, the number of NNS events per minute, anaverage peak pressure, as well as the total number of events per minute.In other examples, a fewer or greater number of parameters as well asdifferent parameters may be considered when evaluating the patient'sgenerated NNS pattern.

The evaluation parameters may be determined using a portion or subset ofthe collected assessment data. For example, a “most active” two-minutewindow having the most number of NNS events is identified by the featureextraction submodule 506. The most-active window is generally indicatedby a bar 1272 on the displayed waveform 1252. When calculating the sixevaluation parameters, the feature extraction submodule 506 may ignoreany NNS activity outside of the most-active window.

After capturing the patient's generated NNS pattern and determining theevaluation parameters, the post assessment review module 508 generates apost-session GUI input form 1274 where the user may confirm the identifyof the patient that underwent the assessment session and input notesregarding the assessment session. By way of example and not limitation,the user may indicate the state of alertness for the patient, byinputting terms such as alert, crying, drowsy, sleepy, or any other termthat identifies the patient's level of alertness during the assessmentsession. The user may further quantify the patient's state of alertnessas active or quiet, as the patient's STI value may fluctuate betweenassessment sessions due to the patient drifting off to sleep during thecapture period.

Once a patient has been diagnosed or characterized as having adisorganized NNS pattern, it is often desirable for the patient toundergo a therapy session to entrain the patient's sCPG to produce anorganized NNS pattern. Typically, a therapy session consists of applyingan external stimulus to or near the lips and mouth of the patient inorder to modify the NNS pattern generated by the sCPG. The orofacialstimulator appliance 108 contacts the patient on or near the lips andmouth to deliver therapeutic stimulation, provided by the pacifier'smotion as caused by the pressure pulses, to the patient's orofacialnerves via regulated changes in the surface diameter of a pacifier 810that is a component of the orofacial stimulator appliance 104, as shownin FIGS. 8B and 9. The pressure pulses conveyed by the orofacialstimulator appliance 108 are actuated at the pulse generator 104 systemin response to a therapy pulse profile generated by the therapy module304.

When a therapy session is to be performed, the NNS application systemmodule 300 generates a main therapy GUI input form 1276, as shown inFIG. 27. The main therapy GUI input form 1276 includes a control button1278 to allow a user to start new therapy session. The main therapy GUIinput form 1276 also includes a control button to display previoustherapy session data 706 stored in the data source 104, the therapysessions data 706 includes summaries and detailed information forprevious therapy sessions.

In one aspect, the therapy module 304 includes a number of submodules600-606, including but not limited to a therapy configuration submodule600, a therapy calibration submodule 602, a therapy execution submodule604, and a post-therapy review submodule 606. The various submodules600-606 generate one or more GUI input forms for display that allow theuser to configure, execute, and review a therapy session.

The therapy configuration submodule 600, for example, generates atherapy configuration input form 1280. The assessment configuration GUIinput form 1280 includes a number controls 1282-1286 related to thetherapy session and the pacifier 810 of the orofacial stimulatorappliance 108. The assessment configuration GUI input form 1280 alsoincludes a control button 1288 that allows the user to select or modifyone or more therapy pulse profiles.

A therapy pulse profile consists of one or more therapeutic waveformsthat result in variable but controlled radial displacements of the outersurface of the pacifier 810. The surface displacements of the pacifier810 provide a tactile stimulus to or near the lips and mouth (e.g.,intraoral, anterior tongue tip, anterior tongue dorsum) of the patientto entrain the patient's sCPG to naturally produce an NNS pattern thatmimics the generated therapy waveforms. Once configured, the therapywaveforms are actuated by the pulse generation system 106, as shown inFIGS. 8A and 9.

The therapy calibration submodule 604 functions similar to theassessment calibration submodule 502 and generates a therapy calibrationGUI input form similar to the assessment calibration GUI input form1250. In one aspect, the calibration GUI input form allows the user tocommunicate with and configure the pulse generation system 106 and theorofacial stimulator appliance 108 to verify the intended function andcalibration of the instruments prior to the start of the therapysession.

In one aspect, the expansion characteristics of the therapy pulses asdelivered by expansion of the pacifier are verified using a lasermicrometer (not shown) in communication with the therapy calibrationsubmodule 604. The data from the laser micrometer regarding thefrequency and amplitude components of the therapy pulse at the pacifier810 may be digitized, recorded, and analyzed by the NNS application 204.

The therapy execution submodule 604 captures and displays the patient'sNNS pattern activity during a therapy session. The therapy executionsubmodule 604 may generate a display 1290, as shown in FIG. 29, thatshows progress of the therapy session at the start of the session,during the therapy session, at a rest interval, and at the conclusion ofthe therapy session, respectively. In other aspects, fewer or a greaternumber of displays may be provided during the therapy session.

Similar to an assessment session, the therapy session may be initiatedby input received through the start control button 1278 of the GUI inputform 1276. Alternately, the therapy session may be initiated by theswitch 816 on a handpiece 806 of the orofacial stimulator appliance 108.

After a therapy session, the post-therapy review submodule 606 generatesa post-session GUI input form similar to the assessment post session GUIinput form 1274 where the user inputs notes regarding the therapysession. The user may indicate the state of alertness for the patient,such as alert, crying, drowsy, or sleepy.

The NNS application 204 further includes a leak detection module 306.The leak detection module 306 continuously monitors the performance ofpneumatic subsystems within the pulse generator system 104 and thepneumatic lines and connections of the orofacial stimulator appliance108 to detect air leaks.

In one aspect, the leak detection module 306 determines that there maybe an air leak by identifying reduced pulse amplitudes, increased pulseroll-offs, and/or the need for a greater stroke length in an air pump ora pneumatic pulse generator 804 to generate the requested pressure.Further, the leak detection module 306 can identify air leaks caused bydisconnected air lines, and poorly seated receiver tubes or pacifiers.The module 306 will display a warning 1292, as shown in FIG. 30,requiring the user to address the leak. The leak detection module 306may monitor the NNS application system 100 automatically andcontinuously during both assessment and therapy sessions.

The NNS application 204 also includes the research module 308 thatallows a user of NNS application system 100 to conduct various researchexperiments and protocols. In particular, the research module 308receives and transmits data to an input/output (I/O) port of thecomputing device 102 or the real-time controller 800 of the pulsegeneration system 106. The I/O port, in turn, may be in communicationwith any of a variety of external instruments for conducting research.

In various other aspects, the NNS application 204 may include additionalmodules for other functions, including those typically associated withmedical or rehabilitation facilities. By way of example and notlimitation, the NNS application 204 may also include a billing module tointerface with an existing billing system or a printing module forprinting various data, charts, or reports.

The NNS Therapeutic Appliance Assembly

Referring now to FIGS. 1, 8A-B, and 9, the NNS Therapeutic applianceassembly includes the pulse generation system 106 and the orofacialstimulator appliance 108. One or both of the pulse generation system 106and the orofacial stimulator appliance 108 may be configured for eachpatient. By way of example, and not limitation, the size, shape, and/ortype of pacifier 810 may be changed between patients.

The orofacial stimulator appliance 108 includes the handpiece 806 andthe pacifier 810 that are brought into contact with the patient todeliver the therapeutic stimuli. In one aspect, the handpiece 806includes a receiver tube 812 in fluid communication with the interior ofthe baglet or pacifier 810. The receiver tube 812 includes an interiorvoid for receiving a volume of air from the pneumatic pulse generator804 or from the pacifier 810. Optionally, the handpiece 806 alsoincludes a receiver tube insert 814, that may be inserted in to thereceiver tube 812 to limit the total volume of air in the interior voidof receiver tube. The handpiece 806 may also include a mode valve 922that is opened or closed depending on whether an assessment session or atherapy session is to be performed.

During an assessment session, the computing device 102 may record anddisplay a signal received from a pressure transducer 808 of theorofacial stimulator appliance 108, as shown in FIG. 8B. The transducer808 translates pressure changes caused by sucking and mouthing movementsof the patient into an analog signal that tracks the pressure applied toa pacifier 810 versus time. The analog pressure signal is converted to adigital signal at an analog-to-digital converter 802 of the pulsegeneration system 106, as shown in FIG. 8A. The analog-to-digitalconverter 802 is incorporated into a real-time controller 800, thatreceives and modifies received and/or generated pressure signals inreal-time. The digital pressure signal is then received, recorded, anddisplayed by the assessment module 302.

Similarly, in one aspect of a therapy session, the pulse generationsystem 106 receives amplitude data 900 and pulse duration data 902 forthe desired waveforms. The amplitude data 900 and the pulse durationdata are provided to the real-time controller 800 which may include anH-bridge (not shown) and a proportional—integral—derivative controller(PID controller) 904. By way of example and not limitation, the PIDcontroller 904 may be a CompactRIO controller. The PID controller 904generates a signal 906 that is fed through a pulse-width modulation(PWM) component 908. The modulated signal 910 is then provided to amotor 912 of the pneumatic pulse generator 804. In one embodiment, thepneumatic pulse generator 804 consists of a linear motor 912mechanically engaged to an air cylinder, such as but not limited to anAirpel airpot or other device having a piston fitted in a precision borecylinder with position and pressure feedback sensors in communicationwith the PID controller 904. The pulse generator 804 also includes aposition feedback sensor 916 to monitor the position of the piston ofthe dashpot 914 and a pressure feedback sensor 918 to monitor thepressure with the dashpot 914. The air displaced by the pneumatic pulsegenerator 804 is then transmitted to the handpiece 806, through one ormore pneumatic airlines, where the therapy waveform displaces the outersurface of the pacifier 810. The pulse generator 804 may also include avent valve 920 that is normally closed, however the valve may be openedand vented to atmosphere to ensure pressure equilibrium at the start ofeach assessment or therapy session. Optionally, the pulse generator 804may also include another valve (not shown) that isolates the dashpot 914from the handpiece 806 during a Power-On Self Test (POST). The optionalvalve therefore permits diagnostic testing of the application system100.

The Therapeutic Waveform

Preferably, the therapy waveform consists of one or more salienttherapeutic bursts and each burst contains two or more square wavepulses. Typically, the bursts are separated by a configurable andvariable delay interval.

According to one aspect, the nominal number of pulses in a desiredtherapeutic burst is six, while the actual number is configurable byusers of the NNS application system 100. Preferably, each pulse in atherapeutic burst is a square wave pulse having the same configurableamplitude. Further, the period of each pulse increases sequentiallythereby, causing the waveform frequency to slow down from the start ofthe therapeutic burst to the end of the therapeutic burst. A desirabledecelerating sequence pulse sequence has periods of approximately 510±3ms, 526±3 ms, 551±3 ms, 580±3 ms, and 626±3 ms between therapeuticbursts. When more than five pulses are used in the therapeutic burst,the sixth and all subsequent pulses have an periodic interval ofapproximately 626 ms.

Preferably, each square wave pulse period is shaped to minimize thepositive and negative rise/fall times. For example, the transitionintervals of each pulse's leading or trailing edges between each pulsemay be tuned to create harmonics of 1.7±0.5 Hz, 5.5±0.5 Hz, 9.0±0.5 Hz,12.5±0.5 Hz, and 16.5±0.5 Hz. It is desired that the therapy waveformhave minimal ringing or flutter at the square wave peaks, in order to beperceived as a “clean” square waves. As the therapy pulse profiles maybe modified in the amplitude and frequency domains, a power spectrumanalysis shows that the preferred therapy waveform generatesdisplacement of the pacifier 810 at a fundamental frequency ofapproximately 1.7 Hz and higher orders. This fundamental frequency ispreferred to entrain the patient's nervous system through cutaneoussignal detection. Further, the preferred therapy waveform has a Q factorgreater than or equal to 1/2. As such, the relative high frequency ofthe rising and falling edges of the therapy pulse helps to achievestimulus salience in the patient.

In all aspects, the number of square wave pulses per therapeutic burst,the number of therapeutic bursts per therapy session, and the amplitudeof the square wave pulses are configurable by the user to account forvariability in the patients. For example, the age, endurance, and/oraptitude of the patients may vary, thereby requiring the user to selector modify a therapy pulse profile via the therapy configurationsubmodule 600.

Methods of Using the Non-nutritive Suck Entrainment System (EntrainmentSystem)

FIG. 10 illustrates a method for performing an assessment session tocapture and analyze a patient's NNS pattern in accordance with an aspectof the NNS system 100. At step 1000, a user of the NNS system 100selects a patient from a displayed list of patients. The user thenselects a control button to enter the assessment mode of the NNSapplication 204 at step 1002 and selects the “start new assessment”control button 1224 at step 1004. The assessment session is configuredas desired at step 1006 based upon the patient's age, injury, or otherpatient data 702 and optionally, data 704 regarding the patient'sassessment history. The orofacial stimulator appliance 108 is calibratedat step 1008, while the patient is positioned to encourage a rootingresponse to the orofacial stimulator appliance at step 1010. At step1012, the assessment session is started, while the orofacial stimulatorappliance is contacted with the patient's lips and mouth at step 1014.In other aspects, the orofacial stimulator appliance 108 is insertedinto the patient's mouth at step 1014. Similarly, in other aspects, thesteps 1012 and 1014 may be reversed.

Once the assessment session is completed, the orofacial stimulatorappliance 108 is removed from the patient at step 1016. After thefeature extraction submodule 406 analyzes the collected assessment data,using the input form 1274 generated by the post-assessment review module508. After the assessment session, the user may initiate anotherassessment session for the same patient or a different patient.Alternatively, the user may instead exit the NNS application 204.

FIG. 11 illustrates a method for performing a therapy session to entraina patient's sCPG to generate an organized NNS pattern in accordance withan aspect of the NNS application system 100. At step 1110, a user of theNNS application system 100 selects a patient from a list of patients.The user then selects a control button to enter the therapy mode of theNNS application 204 at step 1102 and the selects a “start new therapy”control button 1278 at step 1104. The therapy pulse profile to begenerated during the therapy session is selected from the therapy pulseprofile data 708 at step 1106 and at step 1108, the therapy pulseprofile is configured as desired based upon the patient's age, injury,or other patient data 702 and any of the patients NNS assessment data704. The orofacial stimulator appliance 108 is calibrated at step 1110,while the patient is positioned to encourage a rooting response to theorofacial stimulator appliance at step 1112. At step 1114, the therapysession is started, while the orofacial stimulator appliance iscontacted with the patient's lips and mouth at step 1116. In otheraspects, the orofacial stimulator appliance 108 is inserted into thepatient's mouth at step 1116. Similarly, in other aspects, the steps1114 and 1116 may be reversed. During the therapy session, the user mayattempt to hold the patient as still as possible.

Once the therapy session is completed, the orofacial stimulatorappliance 108 is removed from the patient at step 1118. The user mayprovide summary remarks regarding the therapy session at step 1120 usingthe GUI input form 1274 generated by the post-therapy review module 606.After the therapy session, the user may initiate another therapy sessionfor the same patient or a different patient. Alternatively, the user mayinstead exit the NNS application 204.

Therapy sessions may be performed multiple times in the same day, week,or month. For example, a therapeutic session may consist of at least sixpressure pulses in succession contacted with the patient for at leasttwo minutes, at least twice a day. In other examples, a greater or fewernumber of pressure pulses may be applied in succession or periodically.

It will be appreciated that the device and method of the presentinvention are capable of being incorporated in the form of a variety ofembodiments, only a few of which have been illustrated and describedabove. The invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive and the scope of the invention is, thereforeindicated by the appended claims rather than by the foregoingdescription. All changes, which come within the meaning and range ofequivalency of the claims, are to be embraced within their scope.

What is claimed is:
 1. A method for using a non-nutritive suck applianceassembly in communication with a non-nutritive suck application system,the method comprising: at a user interface generated for display on adisplay device of the non-nutritive suck application system: selectingthe patient's name from a displayed list of patients generated by thenon-nutritive suck application system, the non-nutritive suckapplication system having memory and executing a non-nutritive suckapplication on at least one processor; selecting an assessment mode ofthe non-nutritive suck application; selecting a displayed “newassessment” control button selecting an assessment session to beperformed at the user interface; and, configuring the assessment sessionat the user interface; calibrating an orofacial stimulator appliance ofthe non-nutritive suck appliance assembly to perform the selectedassessment session; positioning the patient to encourage a rootingresponse to the orofacial stimulator appliance; starting the assessmentsession; inserting the orofacial stimulator appliance into the patient'smouth; holding the orofacial stimulator appliance to maintain contactwith the patient's mouth during the assessment session; removing theorofacial stimulator appliance from the patient's mouth at theconclusion of the assessment session; and, providing summary remarksregarding the assessment session at the user interface.
 2. The method ofclaim 1, wherein calibrating the orofacial stimulator appliancecomprises mounting a pacifier onto an end of the orofacial stimulatorappliance.
 3. The method of claim 1, wherein the assessment session isstarted by selecting a “start assessment” control button at the userinterface.
 4. The method of claim 1, wherein the assessment session isstarted by depressing a button on the orofacial stimulator appliance. 5.The method of claim 1, wherein the summary remarks comprise dataregarding a state of alertness for the patient.
 6. The method of claim 1further comprising: providing power to the non-nutritive suckapplication system; providing power to the non-nutritive suck applianceassembly; verifying a charge of a battery back-up unit; and logging into the non-nutritive suck application.
 7. The method of claim 1 furthercomprising: adding a new patient to the displayed list of patients,wherein adding a new patient comprises: selecting an “add new patient”control button at the user interface; entering new patient data at theuser interface; and, selecting a “save” control button to save the newpatient data in the memory of the non-nutritive suck application.
 8. Amethod for using a non-nutritive suck appliance assembly incommunication with a non-nutritive suck application system, the methodcomprising: at a user interface generated for display on display deviceof the non-nutritive suck application system: selecting the patient'sname from a displayed list of patients at a user interface generated bythe non-nutritive suck application system, the non-nutritive suckapplication system having memory and executing a non-nutritive suckapplication on at least one processor; selecting a therapy mode of thenon-nutritive suck application; selecting a displayed “new therapy”control button; and, configuring a therapy protocol to be performed;calibrating an orofacial stimulator appliance of the non-nutritive suckappliance assembly to perform the selected therapy protocol; positioningthe patient to encourage a rooting response to the orofacial stimulatorappliance; starting the selected therapy protocol; inserting theorofacial stimulator appliance into the patient's mouth; holding theorofacial stimulator appliance to maintain contact with the patient'smouth during the therapy protocol; removing the orofacial stimulatorappliance from the patient's mouth at the conclusion of the therapyprotocol; and, providing summary remarks regarding the therapy protocolat the user interface.
 9. The method of claim 8, wherein calibrating theorofacial stimulator appliance comprises: inserting a therapy insertinto a receiver tube of the orofacial stimulator appliance; and,mounting a pacifier onto an end of the orofacial stimulator appliance.10. The method of claim 9 further comprising measuring a frequency andan amplitude of at least one pacifier displacement with a lasermicrometer.
 11. The method of claim 8, wherein the therapy protocol isstarted by selecting a “start therapy” control button at the userinterface.
 12. The method of claim 8, wherein the therapy protocol isstarted by depressing a button on the orofacial stimulator appliance.13. The method of claim 8, wherein the summary remarks comprise dataregarding a state of alertness for the patient.
 14. The method of claim8 further comprising: providing power to the non-nutritive suckapplication system; providing power to the non-nutritive suck applianceassembly; verifying a charge of a battery back-up unit; and logging into the non-nutritive suck application.
 15. The method of claim 8 furthercomprising: adding a new patient to the displayed list of patients,wherein adding a new patient comprises: selecting an “add new patient”control button at the user interface; entering new patient data at theuser interface; and, selecting a “save” control button to save the newpatient data in the memory of the non-nutritive suck application. 16.The method of claim 8, wherein the summary remarks comprise dataregarding a state of alertness for the patient.
 17. The method of claim8, wherein the step of holding the orofacial stimulator appliance tomaintain contact with the patient's mouth during the therapy protocolfurther comprises: at the non-nutritive suck application system,generating a therapeutic pressure pulse profile signal comprising a basefrequency signal further comprising two or more pressure pulses, whereineach pressure pulse causes a displacement of a pacifier surfacecontacted by the lip and the mouth of the patient, wherein each of thetwo or more pressure pulses has a square wave profile and are separatedby an interval between 500 milliseconds and 650 milliseconds induration.
 18. The method of claim 17, wherein the therapeutic pressurepulse profile signal comprises at least six pressure pulses insuccession contacted with the patient for at least two minutes, at leasttwice a day.